Cardiac valve leaflet enhancer devices and systems

Abstract

The disclosure relates to a device that is configured to be implanted on the native leaflet of a heart valve to increase its length and/or thickness and thereby to improve the valve function and reduce regurgitation. The device may include a leaflet section. The leaflet section may include a central member. The central member may include a first portion, a second portion that opposes the first portion, and a base portion disposed between the first portion and the second portion. The first section may extend from the first portion and the second section may extend from the second portion. The device may include one or more engaging members extending from the central member at an angle with respect to the first section and the second section. The second section may be larger than the first section. The leaflet section may define a three-dimensional region or a bulge.

What is claimed is: 
     
       1. A leaflet enhancer device, comprising:
 a leaflet section, the leaflet section defining a three-dimensional region and including a central member, the central member including a first portion, a second portion that opposes the first portion, and a base portion that is disposed between the first portion and the second portion; 
 a first section extending from the first portion; 
 a second section extending from the second portion, the second section larger than the first section and including an opening; and 
 one or more engaging members extending at an angle from the central member, 
 wherein the first section and the second section are at least partially coplanar and the first section is biased towards the second section such that the first section is disposed within the opening of the second section. 
 
     
     
       2. The device according to  claim 1 , wherein:
 the first portion and the second portion have a curved profile. 
 
     
     
       3. The device according to  claim 2 , wherein the first portion and the second portion protrude towards a direction relative to the planar profile of the first and second section to define a convex curved profile. 
     
     
       4. The device according to  claim 1 , wherein the one or more engaging members includes a first set of engaging members extending from the first portion and a second set of engaging members extending from the second portion. 
     
     
       5. The device according to  claim 4 , wherein the first set of engaging members includes less engaging members than the second set of engaging members. 
     
     
       6. The device according to  claim 1 , further comprising:
 a covering member, the covering member being disposed on and surrounding at least the leaflet section. 
 
     
     
       7. The device according to  claim 1 , wherein:
 the device is configured to move between (i) a default, closed position and (ii) an open position; and 
 in the closed position, the first and second sections are configured to compress upon opposite surfaces of the native leaflet when the device is implanted. 
 
     
     
       8. The device according to  claim 1 , further comprising:
 one or more gripping members extending from a surface of the first section and/or a surface of the second section. 
 
     
     
       9. The device according to  claim 8 , further comprising:
 one or more plates configured to be attached to the first section and/or the second section, the one or more plates including the one or more gripping members. 
 
     
     
       10. The device according to  claim 9 , wherein the one or more plates includes a portion that extends within the leaflet section. 
     
     
       11. A leaflet enhancer device, comprising:
 a leaflet section defining a three-dimensional region; 
 a first section extending from the leaflet section; and 
 a second section extending from the leaflet section, the second section including an opening; 
 wherein:
 the second section is larger than the first section; 
 the device is configured to move between (i) a default, closed configuration and (ii) an open configuration; 
 the device is biased to the closed configuration; 
 in the closed configuration, the first section is biased towards the second section so that the first section and the second section are at least partially coplanar and the first section is disposed within the opening; and 
 in the closed configuration, the first section and the second section are configured to impose a compressive force on opposite surfaces of a native leaflet captured there between. 
 
 
     
     
       12. The device according to  claim 11 , wherein:
 the leaflet section including a central member, the central member including a first portion, a second portion that opposes the first portion, and a base portion that is disposed between the first portion and the second portion; 
 the first section extends from the first portion; and 
 the second section extends from the second portion. 
 
     
     
       13. The device according to  claim 11 , further comprising:
 one or more engaging members extending from the central member at an angle with respect to the first section and the second section. 
 
     
     
       14. The device according to  claim 13 ,
 wherein the one or more engaging members includes a first set of engaging members extending from the first portion and a second set of engaging members extending from the second portion. 
 
     
     
       15. The device according to  claim 12 , further comprising:
 a covering member, the covering member being disposed on and surrounding at least the leaflet section. 
 
     
     
       16. The device according to  claim 12 , wherein:
 the first portion protrudes towards the second portion; and 
 the leaflet section is configured to surround an edge of the native leaflet. 
 
     
     
       17. The device according to  claim 11 , further comprising:
 one or more gripping members extending from a surface of the first section and/or a surface of the second section. 
 
     
     
       18. The device according to  claim 17 , further comprising:
 one or more plates configured to be attached to the first section and/or the second section, the one or more plates including the one or more gripping members. 
 
     
     
       19. The device according to  claim 18 , wherein the one or more plates includes a portion that extends within the leaflet section. 
     
     
       20. The device according to  claim 11 , wherein the device is configured to be delivered using a delivery catheter, the delivery catheter being configured to deliver the device in the open configuration to the native leaflet and move the device to the closed configuration for attachment to the native leaflet.